DE69626016T2 - Test kit and devices - Google Patents

Abstract

A test kit for determining qualitatively or quantitatively the presence of one or more analytes in a fluid sample, comprising an assay device (600) together with a reading device which engages with the assay device (600) and wherein precisely located engagement of the assay device with the reading device is essential for accurate reading of the assay result, wherein precisely located engagement of the assay device with the reading device causes a 'lock-and-key' interaction, ie. a unique 3-dimensional interaction, between the assay device and reading initiation means of the reading device. Preferably the reading initiation means includes switch actuating means comprising at least one fixed projecting portion (301,302) and at least one displaceable projecting portion (300), and a contact portion of the assay device casing comprises a recess (703,704) shaped to accommodate the fixed projecting portion (301,302) of the switch actuating means but not the displaceable projecting portion (300) thereof, the contact portion also comprising an interface portion (705) that contacts and displaces the displaceable portion (300) of the switch actuating means when the fixed projecting portion (301,302) is accommodated within the recess (703,704). <IMAGE>

Description

TECHNICAL TERRITORY

The present invention relates focus on test kits and devices for qualitative or quantitative Determination of the presence of one or more analytes in one liquid Sample and especially on means to simplify the correct Interrelation between an assay device and one intended for it Reading device, which together constitute essential parts of the test kit.

STATE OF THE ART

In our own PCT registration WO 95/13531 we have described reading devices for assay devices using test strips. Typically, the assay device has an elongated housing that contains the test strip and has one or more "windows" in the housing through which an area or zone of the test strip can be observed with the result of the detection procedure. The preferred The reading device in this case comprises a receiving section with a slot, in which the assay device can be used and in which the result of the detection is determined by electromagnetic devices, in particular on the basis of the transmission of light through the test strips of the test strip are correctly positioned within the reading device relative to the beam path or other features that make up the system for reading the results WO 95/13531 describes various possibilities with which the correct inclusion of the assay device inside the reading device can be simplified.

There is a primary objective with these test kits in that they are also used by untrained personnel and in particular should be usable at home by the user. Becomes the normal user to use any device asked the one physical Intervention of one unit with another requires, then it for this one Process surprising frequently happen that it is executed incorrectly.

Carefully formulated and illustrated instructions provided by the manufacturer can be misunderstood or are often completely ignored. In connection with the present invention, in which a precise reading of the result of a sensitive detection is required, it is very important that an exact placement of the assay device is achieved within the reading device. Any misalignment or incorrect intervention between these two units can result in an inaccurate or misleading reading of the assay result. This problem is particularly pressing where the reading system has no way of scanning the assay device to locate the correct section that should be read. The cost and the complex structure of the reading system can be considerably reduced if the precise position of the detection zone within the detection zone is controlled during manufacture and the device is positioned relative to the reading device in a constant manner so that the detection zone is always the same position relative to the Reading system. An object of the invention is to provide a test kit that significantly reduces the likelihood of a user-caused error while aligning the assay device with the reading device. A related objective is to create a test kit in which the reading of the assay device is only initiated if the assay device is actually correctly positioned relative to the reading device, or in which the user receives an alarm message that the assay device is Device is incorrect. In the pre-release WO 95/13531 While we have described some mechanisms that facilitate precise placement, the present invention offers other improvements.

In the European patent specification EP 0 376 111 discloses a substantially flat combination of an assay device and a detection reading device, in which the detection reading device comprises a positioning device which enables the assay device to be positioned exactly relative to the detection reading device. A precise three-dimensional meshing between the assay device and the detection reading device is not provided.

The invention is described below with specific reference to test kits useful for monitoring analytes from body fluids and especially monitoring of analytes from the urine at home which are relevant for determining status in the ovulation cycle in humans. This proof is only described here by way of example and it goes without saying that the invention is also useful in a number of other contexts in which other sample liquids and analytes play a role. Examples of other types of analysis where precise assay results are desirable and where a kit or detection arrangement according to the invention may be appropriate include detection or assays for cancer markers, heart markers, blood glucose levels, addictive drugs , Hormones, markers for infectious diseases, examinations for monitoring and in the manufacture of medicines for therapeutic purposes and quality control the raw materials for this, and tests for the detection of pollution levels in waste water and for the detection of environmental pollution.

GENERAL DESCRIPTION THE INVENTION

A test kit is proposed according to the invention for the qualitative or quantitative determination of the presence of one or more analytes in a liquid sample comprising one Assay device together with a reading device using of the assay device, which is the precise engagement the assay device with the reading device for the exact reading of the assay result is essential, the reading device a receptacle for receiving the assay device and a reading initiator comprises a switching element or the like, of which at least part when the assay device is accommodated in the receptacle is adjustable, which is characterized in that the precise engagement of the assay device with the reading device causes that a contact part of a housing the assay device contacts the switching element, wherein the contact part and an adjustable part of the switching element via a "lock-key" intervention in this way are mutually engaged with each other, that only with correct admission the switching element can be adjusted to the assay device to start reading.

In connection with the present Description is the term of an interaction in the manner of a "lock-key" intervention as a label for one only one-time three-dimensional spatial relationship between the assay device and the reading device. Both here in detail described preferred embodiments the invention results from the alignment of these two components along three axes. This three-axis alignment is evident in one operation a switching device along a single axis, with which reading of the assay device is initiated.

In one embodiment, the assay device is executed in the way that they are essentially made of a porous carrier strip or the like inside a hollow case and where the result of proof by a specific connection of a labeled reagent within a detection zone of the carrier strip is displayed, with the presence of the highlighted reagent can be recognized by the reading device within the detection zone can.

In connection with the present Invention, the term "switching element" is used in the sense that it designates every device or means that switches on or switching off an electrical or electronic circuit directly or indirectly caused or their change in the sense that it initiates the reading of the result of a verification process or affects them. In the typical case it is a mechanical mechanism. The actuator can be part of an actual switch or directly, i.e. physically, associated with it, or it can be an indirect one Connection or a remote connection may be provided. The one here important thought is that a correct mesh between the assay device and the reading device and affects only the switching element and consequently the necessary electrical or electronic change takes place.

The switching element has cheaper Manner at least one fixed projecting section and at least one displaceable projecting section, and the Contact part of the housing the assay device has a recess which is shaped so that they have the fixed protruding portion of the switching element records, but not its relocatable section above, the contact part also has a Kop pelteil, with the displaceable portion of the Contact in contact comes and this shifts when the fixed projecting section is accommodated within the recess.

The receiving device preferably comprises a biasing means that opposes the assay device received the switching element presses.

In another preferred embodiment the receiving device has a curve member, which the assay device moved away from the switching element unless the assay device was recorded correctly. Ideally, the curve link provides a "snap" intervention between the assay device and the receiving device when the assay device was recorded correctly.

The assay device is a supplementary feature preferably elongated and the receiving device has a Slot into which at least a portion of the elongated assay device can be fitted while the slot has at least one protruding nose section, who is about the opening of the slot and is effective such that the assay device is held in the slot when inserted correctly is. In a preferred embodiment the protruding nose portion is at one end of the slot and can during inserting the assay device into the receiver engaging one end of the elongated assay device come. A second protruding nose section is also preferred provided at the other end of the slot or in the vicinity thereof, likewise to hold the assay device in it.

A special embodiment of the Erfin is now explained in detail using the 1 to 10 described in the accompanying drawing. This drawing is for general illustration only and is not drawn to scale. In addition, the reader of the present description should also consider the technical content of the prior publication WO 95/13531 pull in with. The present invention is solely related to ensuring precise engagement between the assay device and the reading device. The manner in which the assay device generates a readable detection signal is not critical, and the mechanism by which the readout device reads and analyzes this signal and provides information to the user is also not critical. Examples of all of these considerations are in the prior publication WO 95/13531 explained.

SUMMARY THE DRAWING

1 shows a reading device according to the invention in a general view, with a lid open, thereby revealing the main features of the device that are important to the user.

2 represents part of the in 1 shown device in plan view, wherein a slot for receiving an assay device can be seen in detail.

3 FIG. 3 shows the reading device partially in cross section, which is laid along the longitudinal axis of the slot, the rear wall of the slot being shown.

4 represents the reading device partially in cross-section, which is placed along the longitudinal axis of the slot, but looking in the opposite direction, the opposite wall of the slot being shown.

5 represents a partial elevation looking in the slot from the right end and along the slot.

6 Figure 4 shows a general view of an assay device as the user holds it in an orientation in which it can be inserted into the reading device.

7 shows the opposite side of the assay device in a general view.

8th Figure 12 is an elevation view of the reader and assay device during insertion, partially in cross-section, as viewed from the front of the reader.

9 is a partial top view of the slot with the assay device correctly inserted therein, partially in cross-section and partially in broken-away view.

10 is an enlarged plan view of the mechanism with the switching element, partially in cross section, in which the mechanism for the switch actuation on the reading device is shown.

It is now going on 1 referred to, according to which the reading device has a generally flattened oval body 100 and an upper lid 101 has at the back 102 the body is articulated. Each side 103 of the lid 101 is steeply bent inward near the joint and the body 100 points across its surface 104 a recess so that when the lid is closed the device has a flush outer surface. In this regard, the shape and proportions of the lid and the body have been designed from a purely aesthetic point of view and have no influence on the present invention. Technically, there is no need for the device to have a lid at all. The surface 104 the device released from the opened lid has a recess 105 to the right 106. The deepening 105 has an inclined rear surface 107 , which includes a number of operational features that are important to the user. While these operating features are not directly relevant to the present invention, they can be performed as shown in FIG 1 a push button 108 , two indicator lights 109 and 110 and a small display screen 111 to convey information to the user. The deepening 105 has a flat bottom 112 , At the left end 113 the deepening 105 is a sloping surface 114 provided, from the center of which there is a receiving slot 115 extends horizontally to the left side 116 of the device. The slot 115 runs almost entirely on the left side of the device and ends under a small glazing 117 which is molded into the top of the device. According to 1 is the back wall 118 of the slot 115 to recognize the mechanics 119 for switch actuation with which the reading of an assay device (not shown here) initiates when it is inserted into the slot; furthermore is a rectangular cover 120 of a reading system (hidden in the body of the reading device), with which information can be obtained from an inserted assay device. The desk 119 will be explained in more detail below using the 3 . 9 and 10 described. The flat bottom 112 the depression extends into the slot. On the right 121 of the depression 105 extends directly opposite the end 122 the slot the edge 123 the device in a convex curved fore to a tip 124 down that is directly in line with the longitudinal axis of the slot. On the inside surface of the lid 101 is a little deepening 125 provided the glazing 117 at the end of the slot when the lid is closed. Other features of the in 1 Recognizable slot consist in the fact that this has essentially parallel sides over most of its length, but that there is an area 126 the next the closer it is to the glazing, the more slightly it tapers inwards conically. At the other open end 122 the slot is a nose extending forward 127 on the top edge 128 the rear wall 118 intended. The slot has at its open end 122 its greatest width, since both the front wall and the rear wall in the areas 129 and 130 are each graded outwards.

In 2 are the same characteristics of the slot 115 recognizable even more clearly. Other features included in 2 are seen to be the rectangular cover 120 for the reading system from the rear wall 118 of the slot 115 extends outwards and clearly bevelled edges 200 having. In the front wall 126 of the slot are two protruding spring-loaded buttons 201 and 202 provided, one of which (201) the switching element 119 directly opposite and the other (202) near the mouth opening 122 the slot is provided, namely opposite the nose 127 , which extends from the rear wall. A second button 202 has a bevelled surface 203 near the mouth of the slot.

3 represents the back wall 118 of the slot 115 represents the switching element 119 is divided into three parts. Overall, its shape is round, but it has a diagonally running central area 300 on, which extends over the entire width of the switching element, and two curved sections 301 and 302 , each lying on one of the two sides of the diagonal. The curved sections are fixed, but the diagonal middle section can be pushed down to trigger the reading from the device. 3 also represents an area 303 of the flat bottom 131 of the slot near the glazing 117 steeply sloping upwards and then onto the end wall 304 of the slot under the glazing.

4 shows the opposite wall 126 of the slot 115 which the two spring loaded buttons 201 and 202 includes. The button 202 is near the mouth opening 122 of the slit asymmetrically shaped and its top 400 is slanted downwards while the left surface 203 (in 4 shown) is also beveled. There is a rectangular depression horizontally between the two buttons 401 , behind which a lighting system (not shown here) is provided, which is part of the mechanism for A reading the device. The deepening 401 is directly opposite the arched cover 120 of the reading system in the opposite wall of the slot. Here too is the sloping area 303 of the floor 131 of the slot under the glazing 117 recognizable.

In the 5 shown view along the slot 115 shows the bottom 500 the protruding nose has a convex curved surface. Other features included in 5 are shown, the beveled push button 202 who have favourited Arched Cover 120 of the reading system, the glazing 117 at the distal end of the slot and the sloping bottom 303 under the glazing.

6 represents an assay device that has an elongated body 600 and a removable cap 601 having. The left section 602 (in 6 recognizable) of the body 600 has a narrower cross section than the main part 603 and tapers steeply at its far left end 604 , This rejuvenation results from the following:

• (a) The front 605 the device is tapered towards the left end; and
• (b) the bottom 606 is steeply angled up at the left end.

There is a long rectangular window 607 in the front 605 of the narrower section 602 of the body is provided which has angled sides 608 which extend into the molded body. This window gives a view of a detection or test strip 609 free inside the device and this strip is shown to comprise two zones 610 and 611 for the result of the test.

According to 7 , which is the opposite side of the assay device, encompasses the opposite surface 700 of the narrower section 602 the body also has a rectangular window 701 , which is embedded in the body. This window also gives a view of the strip 605 and the same detection zones 610 and 611 free, as they are visible through the other window. In the same area of the device is between the window 701 and the extreme tip 702 a pair of arcuate recesses 703 and 704 provided by a diagonal section 705 are separated from each other, which is flush with the rest of the surface of the device at this point.

8th represents the assay device 600 in the state in which it is inserted into the reading device. The summit 702 the body of the assay device was under the glazing 117 placed and stands approximately at the center of the narrower section 602 of the body with the upper part of the push button 201 in contact and lies on this, even if this is not shown in the drawing. This is a stable position and it is the pressure of the user's finger down on the body 603 and / or the cap 601 of the device required to push the device in a more horizontal orientation within the slot against the Resistance the push button 201 opposed, which would be postponed by such a movement. This drawing also shows in broken lines the position that the assay device must assume when it is correctly inserted into the reading device for a precise reading. This correct position assumes that the assay device (relative to the bottom of the reading device) is completely horizontal, with the tip 702 under the glazing 117 fully aligned and the distal end 800 the cap against the inwardly curved section 124 on the left side of the reading device. It can also be seen there that the section running obliquely upwards 606 the top 702 the assay device with the upward slope 303 of the bottom of the slot under the glazing. When the assay device is properly inserted into the slot, the wider section becomes 603 of the body sliding under the protruding nose 127 the rear wall 118 the slot held.

Out 9 it can be seen that the correctly inserted assay device is locked in its position by a combination of features. It is under pressure from the two push buttons 201 and 202 against the rear wall 118 excited at the end. The above cover 120 of the reading system fits exactly into the window recess 701 in the body of the assay device. The fixed curved sections 301 and 302 of the switching element fit precisely into the curved recesses 703 and 704 in the body of the assay device and the diagonal section 300 in the middle of the switch is from the diagonal body section 705 depressed between the two wells. The pressure on the section 300 of the switch causes the assay device to be read using one of the following with reference to FIG 10 mechanism described. The objective here is to provide a very special three-dimensional situation in which the switching element is actuated by the assay device accommodated therein. The position of the glazing 117 and the protruding nose 127 are shown in dashed lines. The wider section 603 the body of the assay device is received in the interior of the outwardly widening opening of the slot.

Other features included in 9 are shown in an illumination system 900 behind an optical diffuser or diffuser 901 in the front wall 126 of the slot and in a series of light sensors 902 behind the cover 120 on the back wall 118 of the slot. These features are simply shown in schematic form because they are not critical to the present invention. Suitable examples of such features are in the prior publication WO 95/13531 described.

Features that are recognizable within the partial cross-section by the assay device consist of the detection strip 609 , which is between a transparent plastic film on both sides 903 and 904 is included in the two detection zones 610 and 611 in the strip and in a pen 905 in the molded part of the assay device, which extends through the detection strip and the foils covering it and thus forms a means for precise localization for the two detection zones during the manufacture of the device. Examples of these features are also fully covered in the prior publication WO 95/13531 described.

10 represents the mechanism for operating the switch in the reading device in more detail. The actual switch 1000 , which is connected to the electronic processing circuit inside the reading device, is located even in the interior of the body 100 of the device and is in the previous drawings only in the partially sectioned view in 9 visible. With the actual unit 119 , which is visible on the rear surface of the slot, is a separate mechanical structure that, in operation, makes contact with the switch 1000 manufactures and operates it. As shown in 10 is the switch 1000 on a circuit board 1001 intended. On the back of the circuit board 1001 there are two switch contacts 1002 and 1003 ,

The mechanical structure, which interacts with a correctly installed detection or test device, is located in the rear wall of the slot. As already described, the mechanics comprise two outer fixed sections 301 and 302 as well as a movable section 300 in the middle, which is moved inwards when the test device has been inserted correctly. As shown in 10 includes the movable section 300 the switching mechanism a hollow shaft 1004 , which rests between the two fixed sections of the mechanics and a bearing between the sections 301 and 302 for unimpeded sliding movement. A bushing extends through the entire shaft in the axial direction 1005 threaded for engagement with a long threaded screw 1006 is provided, which is held inside the shaft. The shaft extends over the inner surface 1007 the wall of the slot and closes in a flange 1008 from. The width of the section of the shaft with the flange is greater than the width of the channel between the two fixed sections of the mechanics, which accommodate most of the back. There is a gap between the flange and the wall of the slot 1009 provided, and within this slot is a coil spring 1010 provided, the ends of which bear against the flange and the inner surface of the wall. The fairy the 1010 acts in such a way that it slightly tensions the shaft in its position so that the end 1011 the screw bears against the switch when the mechanism is in its rest position, which in 10 is shown. The power of the spring 1010 is less than the force required to operate the switch. The threaded screw 1006 extends over the flange 1008 out.

During the manufacture of the reading device, the screw can 1006 so that the outer surface of the shaft lying in the middle 300 is at a distance A and from the tips of the fixed sections 301 and 302 is moved away when a contact is made within the switch. This setting can be controlled during production by detecting the switch contacts.

During the insertion of the assay device in the recommended manner into the reading device - which is very general in 8th is shown - the "tip" of the assay device under glazing 117 inserted and under the pressure of a finger, the assay device is pushed down, pivoting against the pivot point that forms the nose of the glazing, past the various means that protrude from both walls into the cavity of the slot, Is "snapped". The above cover 120 and to a lesser extent the protruding portions of the switching member and the protruding nose 127 act as guide curves that press the body of the device away from the rear wall against the two push buttons. When the assay device is rotated downward and the protruding cover and fixed portions of the switch member begin to engage the corresponding recesses in the body of the assay device, the assay device becomes the rear wall under the pressure exerted by the push buttons of the slot and can "snap" into place under the protruding nose. The curvature on the underside of the protruding nose simplifies this final movement of the assay device into its correct reading position. If the assay device is molded from a plastic material such as polystyrene, as is common today in mass-produced diagnostic devices, it can be flexible enough to deform and facilitate this movement. The inherent elasticity of the molded body of the assay device can actually be used advantageously because the deformation and the subsequent release when the assay device is correctly accommodated inside the reading device can improve the “locking engagement” between these two components of the instrument cluster. The edges of the shaped body of the assay device and of the contact points on the reading device can describe such a radius that they simplify the sliding movement between the two components and avoid situations in which the two components may wedge together.

It is also possible for the user to use the assay device in the slot so that it is in its correct reading position achieved by inserting the tip of the device into the open end of the Slot is used and the device is then horizontal Direction is pushed until it is fully in the target position in the slot has reached. When this alternative process ends, the Assay device by the various described above Interactions precise again held in place.

If in normal operation the assay device is inserted incorrectly into the slot for any reason there is no exact match between these different ones Features. The actuation switch not depressed. If necessary, a supplementary sensor mechanics so involved that they have the presence of an incorrectly inserted Assay device detected and that it may be a Warning signal for is issued to the user, indicating that the assay device is up is not in its correct position.

The body of the reading device, including the walls and the bottom of the slot, can be made from a permanent Plastic material such as polystyrene can be molded. The push buttons and the above sections of the switch actuation mechanics preferably made of a more resistant material, since these parts have repeated contact with the only one time Endure the intended test devices for a longer period of use have to. So called "hard engineering plastics "like for example ABS are for this ideal. This material has good dimensional stability and is harder as polystyrene. The material should have natural load-bearing properties have. An ideal commercial one ABS material is sold under the name "Delrin".

The exact form and the relationship between the various features described above that for one positive three-dimensional interlocking ensure when the assay device are used correctly, are only given as examples. For the knowledgeable readers quickly realize that this is a great variety alternative profiles and constructions are used can to a functionally comparable positive locking effect bring about.

In the background and by way of example, the invention simplifies the creation of reading devices for reading test results and of the associated assay devices for testing samples, both of which provide exact quantitative information can provide proof in a simple, quick and cost-effective manner. Such devices can be used in a wide range of situations, for example in hospitals, clinics, in the doctor's consultation and at home. Depending on the circumstances, the analytes to be examined can also be very different. Examples of this are examinations of organisms or markers for infectious diseases, metabolites in body fluids that provide information about a change in a patient's state of health or illness, as well as administrable or orally ingestible substances such as drugs or drugs in the case of drug abuse. This requires verification formats that can also be carried out by relatively untrained people, especially in the home. Evidence for use at home is primarily intended to determine physiological changes in the human body with the aim of promoting health, general well-being or lifestyle. The health awareness of consumers is becoming more and more pronounced today and this promotes the possibility for consumers to monitor their bodily functions. In some cases, this can also simplify the interaction between the individual consumer and representatives of the medical profession (GP).

There is a lot of evidence, one Indicates physiological changes in the human body deliver that currently only using highly complex laboratory techniques can be made. Now useful Information related to the individual being examined to deliver such evidence generally results in exact numerical results Provide information, e.g. B. Numbers Concentrating a Special Analytes in a body fluid. Accordingly, there is a need for improved detection systems to create that especially for Tests of samples from body fluids can be used at home, and where the convenience examining a sample with a simple and inexpensive numerical determination of the assay result.

Many assay devices are described in the literature, along with suggestions that the assay result can be read using optical instruments. The use of emitted fluorescent radiation or the ability to reflect light are often suggested. Such techniques are in most cases suitable for use in highly developed laboratories, even if the optical reflection behavior is already used in commercially available tests for blood tests for glucose. In the pre-release WO 95/13531 we have described reading systems that work with optical transmission through a detection strip or a comparable membrane.

The combination of assay device / reading device can be delivered to the consumer in the form of a test kit. in the In general, however, the reading device is one comparatively stable Unity that the consumer can use again and again (and the if necessary with an electronic device for data storage and is equipped to process the data so that the results many successive test runs can be evaluated), but are the test devices intended for single use only and will be discarded afterwards. Accordingly, you can the test fixtures for the consumer are delivered separately from the meter, e.g. B. in multiple packaging.

Because a precise locked Interlocking between the test device and the reading device ensured will and also a precise congruent arrangement of the detection zone inside the test device itself is guaranteed, is the test zone for the reading device every time a test device is inserted into the reader is in a constant predetermined position for the reading in front. The structure of the optics inside the reading device (light source and sensors) can therefore be kept as simple as possible since it for the Sensors is not essential that they include any scanning options which is otherwise necessary, for example would be if the precise The location of the detection zone is unknown. By eliminating the need for one sophisticated optics for reading can be avoided Cost of the reader / monitor be reduced. Simplifying the reading optics can also make it possible that the reader / monitor is small, which is convenient and little distracting Supported use at home. If necessary, of course also a scanning facility be included.

Another advantage of the arrangement a built-in possibility to ensure the accuracy of fit, which is a precise location of the detection zone inside the test device ensures that there is an automated manufacturing process and quality control of the test devices can be simplified. For example, in the case of a monitor for monitoring the ovulation cycle it is envisaged that the consumer will use several test devices each month must, must in certain circumstances the test fixtures in large numbers can be manufactured at low cost. A built-in setting Automated manufacturing and a Simplify high production throughput.

In principle, any electromagnetic radiation can be used to make a transmission measurement. The electromagnetic radiation should preferably be suitable for becoming diffuse. The electromagnetic radiation is preferably light in the visible range or close to the visible range. This also includes infrared light and UV light. In general, it is provided that the detectable material used as a marker in a detection is a substance that interacts with light in the visible or near the visible range, e.g. B. by absorption. The wavelength of the selected electromagnetic radiation is preferably at or near a wavelength on which the marking substance has a strong influence, e.g. B. by absorption. For example, if the label is a highly colored substance, that is, if it is visible to the naked eye when the material is concentrated, then the ideal electromagnetic radiation is light with a complementary wavelength. Particulate direct markers, for example in the form of a metallic sol (e.g. gold), a sol made of non-metallic substances in element form (e.g. selenium, carbon), a dye sol and particles of colored latex (polystyrene) are ideal examples of this , In the case of latex particles colored blue, for example, the ideal electromagnetic radiation is red light in the visible range, which is strongly absorbed by the blue particles.

A major advantage of use of diffuse light or other radiation in this context is that the reading of the assay result is clear with less likely to be absent or contaminated the assay device is adversely affected. For example, dirt or scratches on the assay device in the area through which the radiation must be let through, interfering with the accuracy of the determined result if focused light and not diffuse light is used. When using a source of diffuse Light it is possible a reading device for Reading assay results to provide the result of a performed tests even in an essentially transparent one Assay device can evaluate accurately, without being smaller Soiling or damage (e.g. scratches on the surface) disadvantageous on the assay device affect the assay result.

It is desirable that from the radiation source coming electromagnetic radiation is pulsed. If the detectors (Sensors) are synchronized in such a way that they are only in phase work with the pulsed radiation source, it is possible to use any Background interference, caused by external radiation such as light in the environment could be caused to eliminate. In most cases are tests at home under natural Daylight or even more often under artificial Light made. artificial Light is for usually pulsed (typically with a frequency of 50 to 100 Hz) what on the changing Nature of the power supplies. If you now see a pulsed radiation source for illuminating the Assay device inside the reader, so it can penetrate natural Daylight be ignored. By selecting the pulse rate in the Way that these are sufficiently strong from existing artificial Light distinguishes, any artificial interference Light can be avoided. Preferably, the pulse rate should Energy must be at least about 1 kHz. An ideal pulse rate is around 16 kHz. The electronics that are needed to get a synchronized Achieving pulse detection is well known to those skilled in the art. The stake of pulsed light is great Advantage as it makes it unnecessary is that the monitor "against Light shielded " got to. This not only simplifies the construction of the monitor, but also the assay result can also be read with the monitor "open" are made, which simplifies the work for the user.

The light source or the source of everyone other electromagnetic radiation can have completely conventional components. Ideal examples of this are commercially available Light emitting diodes, preferably those that light with a suitable wavelength submit that of which is concentrated in the test area or areas existing detectable material is strongly absorbed. That from The light coming from the LEDs should pass through a strong diffuser guided before it arrives in the assay device. If necessary, can an arrangement of light-emitting diodes can also be used, one after the other be supplied with energy.

Suitable diffusers can for example consist of Plastics are made and are available on the market. If needed, can the properties of the diffuser material during light scattering be improved that particulate substances such as Titanium oxide and barium sulfate are used. An ideal diffuser material contains polyester or polycarbonate containing titanium dioxide. A good value for the share of the particulate involved Material at least about 1% by weight, preferably around 2%. By Can use a diffuser all relevant areas on a verification strip at the same time are measured and there are differences in that emitted by the source Light suspended.

The sensor or sensors for Detection of emerging light can conventional components such as Example be photodiodes, e.g. B. silicon light-emitting diodes.

Preferably there is a second diffuser in front of the sensor or sensors, which can be made of the same material as the main diffuser. This ensures that the sensor's view is not adversely affected whether there is a test strip in the reading head or not. As a result, the monitor can be calibrated even if the test strip is missing and then measure an assay result if the detection strip is present.

If a source with uniform light is used, so it is possible a reading system for test strips and the like to create that against slight deviations in the placement of the test zone or the detection zones of a strip on the other hand, it is relatively tolerant if a scanning sensor is not available is. However, they are quite considerable Advantages in terms of accuracy of detection achieved if controlled the placement of the test zone in the manner described here and is checked.

To improve the proof of probability a conception were already detection devices which allow the user to concentrate monitor the luteinizing hormone (LH) in the urine for about a day shows a steep peak before ovulation. Daily tests to determine the LH concentration in urine, for example performed using the "dipstick" technique, which Assay result is in the form of a colored endpoint whose color intensity is proportional to the LH concentration. Is the consumer one Color table available, with their help the daily The result can be compared with a standard the "LH surge" simply with the naked eye detect. The supervision the LH concentration is unfortunately a very rare example of one Evidence based on semi-quantitative data using this simple technology can be carried out easily are what is possible only because of that is because of the LH increase in relative concentration represents such a clearly recognizable event. Most of them other potentially useful Evidence changed the concentration of the analyte in body fluids becomes considerably finer Way and lets can only be proven with instrumental means.

Therefore there is a need the currently available qualitative test technology for use at home also in the field expand the accurate quantitative detection technique. A cheap one Example that is a logical extension of today's interest Customers at home pregnancy tests and tests to predict ovulation is the expansion to one precise Observation of the ovulation cycle, not only with the aim of estimating the probability a conception to improve but to actually reliable To provide information for contraception purposes. There were already have suggestions made to body fluids to analyze with a view to this goal. A common topic is the observation of periodic fluctuations in the mirror of various hormone breakdown products in urine.

The improved test kits according to this invention can be used in the determination of each analyte in a body fluid, in particular for monitoring the ovulation cycle in humans by determining one or more hormones or their metabolites in a body fluid such as urine, e.g. B. the LH level and / or estrone-3-glucuronide (E3G). In the past few decades, a great deal of research has been done into ways and means of improving "natural" family planning, with physiological parameters that provide information about the status of the ovulation cycle being monitored. In the European patent specification EP-A-706 346 we describe in particular such a method in which the measurement of the estradiol level or the content of breakdown products of estradiol is used, in particular of estrone-3-glucuronide (E3G), in order to obtain a warning about the onset of the fertile phase. Related procedures are described in European patents EP-A-656 118 . EP-A-656 119 and EP-A-656 120 described. Associated test equipment and test kits are described in these patents and also in the prior publication WO 96/09553 described.

In this context, it is provided that a device for examining a liquid sample in the home environment generally comprises a porous carrier material, such as a strip, through which an applied liquid sample such as urine can permeate and in which the assay result by means of a special binding of a detectable substance in a precisely defined area (detection zone) of the carrier is obtained, for example in the form of a narrow line or a small dot, which contains a fixed specific reagent for binding. The invention therefore deals with possibilities in which the location of a detectable material in such a detection zone can be precisely determined in a simple and inexpensive manner. Devices for urinalysis at home, for example during pregnancy tests and tests for the prediction of ovulation, are widely used in the trade today. Many of these devices build on the basics of immunochromatography and typically include a hollow housing made of plastic material and containing a porous detection strip on which previously dosed reagents are applied. The reagents inside the device may comprise one or more reagents labeled with a direct mark such as a dye sol, a metal sol (e.g. gold) or a colored latex (e.g. polystyrene) in the form of microfine particles , The user only needs to apply a urine sample to part of the housing to initiate the detection process. The ace say result is visible to the eye within a few minutes without the user having to take any further steps. Examples of such devices are found in European patents EP-A-291194 and EP-A-383619 described. The sample is conveniently taken with the help of an absorbent part which is part of the device and can easily absorb some sample liquid, for example from the urine stream. Optionally, the absorbent member can protrude from the housing of the device so as to simplify the application of the sample. In addition to the specific examples of detectable materials already mentioned above, other substances can be used which block or reflect the electromagnetic radiation instead of absorbing it, e.g. B. "white" particles such as latex particles in their natural undyed state. Alternatively, the label can be a reactant or catalyst that is involved in the formation of a substance that absorbs or blocks radiation, e.g. B. an enzyme which is used to form a detectable substance, e.g. B. a stained material, in the detection zone with a substrate.

In general, it is provided that the material of the case is opaque, e.g. B. a white or colored plastic material, but the case can be translucent or actually transparent, if desired becomes.

The lighting device can consist of a series of light emitting diodes in a diffuser medium is embedded or arranged behind this, for a uniform and diffuse illumination of the test strip ensures that the reference zone and covered the signal zone.

The inclusion of a diffuser between the openings and the test strip is cheap for calibration purposes. To each of the optical Channels too calibrate if the test strip is not present, it is highly desirable that each detector light from the same areas of the lighting device picks up, as is the case when a test device is available.

The diffuser can be chosen that it is the predominant diffuser in the beam path, so that the introduction of the test strip does not change significantly contributes in the distribution of lighting by the detectors is recorded. In addition, the diffuser element can make it possible that the optical assembly has a "wipeable" surface, what kind of long-term repeated use of the optical assembly is desirable is. By modulating the intensity of the lighting device can the optical channels without moving parts in a way "invisible" to the user before insertion the assay device be calibrated.

The test strip can be made from an optical diffuse layer of nitrocellulose or the like, which preferably between two layers of an optically clear film is included, e.g. B. from a polyester such as Mylar. The clear film protects the nitrocellulose, inside which the detection reactions take place. Taking measurements of reflectivity through thin clear Sliding through foils is particularly difficult because mirror reflections create problems result. The measurement of the light passage enables the optics to be set up perpendicular to the measuring surface and reduces the adverse effects of reflection on one Minimum.

The invention is particularly for Reading of test strips can be used, which are made of nitrocellulose and the like diffuse membranes exist, the strength of which is preferably at most is about 1 mm.

The components of the case can be made from high shockproof or similar Plastic materials such as polystyrene and polycarbonate be shaped and clamped with a sliding fit or threaded screws or any other suitable mechanical means held together become.

It becomes obvious that with regard to the overall interpretation and the general form of the Monitor very significant deviations from those described above Aspects may exist, without departing from the scope of the invention. The general The shape and design of the reading head are determined by the need to interact effectively with the assay device, but this can Shape can be modified considerably. When interpreting and Kind of for accessible to the user actuators and features for displaying information can also vary significantly are present and these are largely based on aesthetic considerations specified.

A person skilled in the electronics field can use the electronics of a monitor device which is capable of assimilating, storing and processing data for the concentration of an analyte and also offers the preferred electronic features of the device described here and, in the corresponding cases, also future events appropriate form, such as the fertility status in the ovulation cycle, can be predicted easily from such data, as soon as he is informed of the factors to be taken into account in such a device and the information which the device is intended to provide to the user , The individual features can be completely conventional; In this context, experts in the field of electronics can be aware that further combinations and arrangements of such features can be used to achieve the goals set in the present invention. For example, instead of conventional microprocessors based on the "chip" technology, so-called "hard-wired" systems and "neural networks" be used.

The information can For example, users with the help of a liquid crystal display or LED display can be conveyed. If necessary, information on the status of fertility using a simple visible Notices are delivered, e.g. B. in the form of a combination of Colors, for example, with green sterile days and with denote red fertile days. Especially when the device primarily used as a contraceptive aid, it should be "foolproof" by gives a signal for "fertile".

Claims (9)

A test kit for the qualitative or quantitative determination of the presence of one or more analytes in a liquid sample, comprising an assay device together with a reading device which is in engagement with the assay device, wherein the precise engagement of the assay device with the reading device for the precise reading of the assay result is essential, the reading device recording ( 115 ) for receiving the assay device and a reading initiator comprising a switching element ( 119 ) Or the like, is adjustable from at least a portion for receiving the assay device in the receptacle, characterized in that precisely located engagement of the assay device with the reading device with the result that a contact part ( 703 . 704 . 705 ) of a housing ( 602 ) of the assay device with the switching element ( 119 ) comes into contact, the contact part ( 703 . 704 . 705 ) and an adjustable part ( 300 ) of the switching element ( 119 ) are mutually engaged with each other via a "lock-key" intervention in such a way that the switching element can only be adjusted to start reading if the assay device has been correctly received. Test kit according to claim 1, characterized in that the assay device is of the type consisting essentially of a porous carrier strip ( 609 ) or the like in a hollow housing ( 602 ) and what an assay result is by specifically binding a labeled reagent in a detection zone ( 610 . 611 ) of the carrier strip ( 609 ) is displayed, the presence of the marked reagent in the detection zone being recognizable by the reading device. Test kit according to claim 1 or 2, characterized in that the switching element has at least one fixed projecting part ( 301 ) and at least one adjustable protruding part ( 300 ) and the contact part of the assay device housing has a recess ( 703 ) which is shaped, the fixed protruding part ( 301 ) of the switching element, but not its adjustable protruding part ( 300 ), the contact part also a coupling part ( 705 ), which comes into contact with the adjustable part of the switching element and adjusts it when the fixed protruding part is received in the recess. Test kit according to claim 3, characterized that the inclusion ( 115 ) Preloading means ( 201 . 202 ) which press the recorded assay device against the switching element. Test kit according to claim 3 or 4, characterized in that the receptacle ( 115 ) a curve link ( 120 ), which bends the assay device away from the switching element, provided that the assay device is not correctly accommodated in the receptacle. Test kit according to claim 5, characterized in that the cam member causes a "snap" engagement between the assay device and the receptacle when the assay device is correctly received. Test kit according to one of the preceding claims, characterized in that the assay device is elongated and the receptacle has a slot into which at least a part of the elongate assay device can be inserted, and that the slot has at least one protruding nose ( 127 ) which extends across the opening of the slot and retains the assay device in the slot when properly received therein. Test kit according to claim 7, characterized in that the protruding nose ( 127 ) is provided at one end of the slot and can engage one end of the elongated assay device during insertion of the assay device into the receptacle. Test kit according to claim 8, characterized in that it has a second protruding nose ( 117 ) at or near the other end of the slot to retain the assay device therein.